

# Event Details

- **Event Name**: US FDA Labeling Requirements for Medical Devices
- **Event Start and End Date**: Thu, 20 Feb, 2025 at 01:00 pm – Thu, 20 Feb, 2025 at 02:30 pm
- **Event Description**: US FDA Labeling Requirements for Medical DevicesAbout this EventDescription:The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinarWhy Should You Attend:Labels and Labeling. Label for various typeds of products or types of submissions. All can be confusing. The FDA looks very carefully at labeling during both device submissions reviews as well as CGMP compliance audits. Problems in label composition, application, and also in their control, handling, issuance, and reconciliation can get a company quickly in trouble. Review the basics of labels / labeling, and see the various areas of application in this webinar, including some little known or controlled areas which are subject to regulatory scruinty by both the FDA, and even a competitor trying to "level the playing field" with their competition.FDA medical device labeling requirements are found in several CFRs, i.e.,General Device Labeling - 21 CFR Part 801;Use of Symbols - 21 CFR Part 801.15;In Vitro Diagnostic Products - 21 CFR Part 809;Investigational Device Exemptions - 21 CFR Part 812;Unique Device Identification - 21CFR Part 830;Good Manufacturing Practices - 21 CFR Part 820;General Electronic Products - 21 CFR Part 1010Add to this the UDI / GUDID requirements, and also court decisions that marketing is labeling. Confusing? This webinar will break these requirements down into the basics and examine means to comply with each category of requirementWebinar Takeaway:Label vs. LabelingBasic CGMPs and LabelingSubmission categories of labeling.Specific required controls.On product, on carton, on shipper labels; IFUsShipper labels - their differencesUDI (and GUDID)Product category differentiationMarketing and "labeling". Who Will Benefit:This webinar will provide valuable assistance to all regulated medical device companies that need to review and ensure their labels / labeling meet current US FDA requirements. The employees who will benefit include:Senior managementRegulatory AffairsQuality AssuranceProductionEngineeringSales and Marketing
- **Event URL**: https://allevents.in/online/us-fda-labeling-requirements-for-medical-devices/100001237015389329
- **Event Categories**: workshops, virtual, webinar
- **Interested Audience**: 
  - total_interested_count: 0

## Ticket Details

- **Ticket URL**: https://consumer.pxf.io/c/1339408/3151484/39691?partnerpropertyid=1191892&MediaPartnerPropertyId=1191892&svlink=14105511&level=1&u=https%3A%2F%2Fwww.eventbrite.com%2Fe%2Fus-fda-labeling-requirements-for-medical-devices-tickets-1237015389329
- **Ticket Price Range**: min: 149.5, max: 398, currency: USD

## Event venue details

- **city**: Online
- **state**: 0
- **country**: 0
- **location**: Online
- **lat**: 0
- **long**: 0
- **full address**: Online

## Event Organizer details

- **affiliate_id**: 10
- **organizer**: Compliance Forus (https://allevents.in/org/compliance-forus/25290245)

## Event gallery

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## FAQs

- **Q**: When is the event happening?
  - **A:** Thu, 20 Feb, 2025 at 01:00 pm
- **Q**: Where is the event happening?
  - **A:** Online
- **Q**: Is this an online event?
  - **A:** Yes, this is an online event.
- **Q**: What is the ticket price?
  - **A:** starting from 149.5 up to 398 USD
- **Q**: Who is organizing the event?
  - **A:** Compliance Forus
- **Q**: What type of event is this?
  - **A:** workshops, virtual, webinar
- **Q**: Where can I find ticket details about US FDA Labeling Requirements for Medical Devices ?
  - **A:** You can find ticket details about this event on AllEvents.